Versions Compared

Old Version 15

changes.mady.by.user Christine Connolly

Saved on

compared with

New Version Current

changes.mady.by.user Christine Connolly

Saved on

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

This is an example of an ADEX dataset and is based primarily on input from the SDTM EX dataset. Other administrative data about the subjects are based on the ADSL dataset provided in Section x.x3.3.6.1, Analysis Data Subject Level Subject-level Analysis Dataset (ADSL).

EX.EXSEQ
Example

Include Page
SDTM Example.ADEX Exposure
SDTM Example.ADEX Exposure

Dataset wrap
NameADEX
Dataset2
STUDYIDUSUBJIDASTDTAENDTASTDYAENDYEXSTDTCEXENDTCTRTPEXTRTEXDOSEEXDOSUSAFFLEXSEQ
A123A20012020-06-262020-07-01Placeboe-nicotine liquid6mLY1A123A20012020-07-012020-07-06Placeboe-nicotine liquid6.4mLY2A123A20012020-07-062020-07-10Placeboe-nicotine liquid7mLY3A123A20082020-07-102020-07-14Product Ae-nicotine liquid8mLY4A123A20082020-09-012020-09-07Product Ae-nicotine liquid5mLY1A123A20082020-09-072020-09-14Product Ae-nicotine liquid7mLY2A123A30092020-09-142020-09-21Product Be-nicotine liquid8mLY3A123A30092020-09-212020-09-28Product Be-nicotine liquid6mLY4
Definexmltable
DatasetADEX
LevelVariable
PurposeAnalysis

Variable Name

Variable LabelTypeCodelist/Controlled TermsCoreCDISC Notes
STUDYIDStudy IdentifiertextEX.STUDYIDUSUBJIDUnique Subject IdentifiertextEX.USUBJIDASTDTAnalysis Start Date

integer

numeric SAS date variable based on EXSTDTC with no imputation for partial dates

AENDTAnalysis End Dateintegernumeric SAS date variable based on EXENDTC with no imputation for partial datesASTDYAnalysis Start Relative DayintegerASTDT-TRTSDT - add one if ASTDT is on or after TRTSDTAENDYAnalysis End Relative DayintegerAENDT-TRTSDT - add one if ASTDT is on or after TRTSDTEXSTDTCtextEX.EXSTDTCEXENDTCtextEX.EXENDTCTRTPtextADSL.TRT01PEXTRTtextEX.EXTRTEXDOSEEX.EXDOSEEXDOSUtextEX.EXDOSUSAFFLtextADSL.SAFFLEXSEQinteger

Include Page
ADaM Example.ADEX Exposure
ADaM Example.ADEX Exposure

Pagenav